Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2020-04-03
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment group
Patients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy.
MiBoFlo Thermoflo
Each treatment for each eye takes 10 minutes and is treated every two weeks for a total of three times. The device was preheated to 42.2℃ and the eyelid was cleaned and smeared with a small amount of ultrasound gel in order to reduce friction between the device and eyelid skin. Then massage the outer skin of the upper and lower eyelids for a period of 10 minutes. The patient's eyes keep closed during therapy.
forceful expression of the meibomian glands
Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
control group
Forceful expression of the meibomian glands only for patients.
forceful expression of the meibomian glands
Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
active control group
LipiFlow® treatment is used as an active comparator.
LipiFlow
LipiFlow treatment applies heat to the palpebral surface of eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces, thereby expressing the meibomian glands during heating.
Interventions
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MiBoFlo Thermoflo
Each treatment for each eye takes 10 minutes and is treated every two weeks for a total of three times. The device was preheated to 42.2℃ and the eyelid was cleaned and smeared with a small amount of ultrasound gel in order to reduce friction between the device and eyelid skin. Then massage the outer skin of the upper and lower eyelids for a period of 10 minutes. The patient's eyes keep closed during therapy.
forceful expression of the meibomian glands
Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
LipiFlow
LipiFlow treatment applies heat to the palpebral surface of eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces, thereby expressing the meibomian glands during heating.
Eligibility Criteria
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Inclusion Criteria
* Meet the diagnostic criteria for dry eye developed by DEWS II: OSDI score≥15 points, TBUT≤10 minutes;
* Meet the signs of meibomian gland dysfunction
Exclusion Criteria
* Had active ocular infection or inflammation;
* Had history of ocular surgery, eyelid surgery or neurological paralysis within 6 months;
* Had history of systemic disease affecting ocular surface function, such as Stevens-Johnson syndrome, Sjögren syndrome etc.
18 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Principal Investigators
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Ying Jie, M.D
Role: STUDY_DIRECTOR
Beijing Tongren Hospital
Locations
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Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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TRECKY2019-099
Identifier Type: -
Identifier Source: org_study_id
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